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Neurotoxin

Botulinum Toxin for Lower Limb Spasticity (PATTERN Trial)

Phase 3
Waitlist Available
Research Sponsored by Merz Pharmaceuticals GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you ever received injections in your lower limb to relax spastic muscles with a drug called botulinum toxin?
If you did NOT receive injections in your lower limb to relax spastic muscles with a drug called botulinum toxin: did the stroke or traumatic brain injury occurred LESS than 36 months ago?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4-6
Awards & highlights

PATTERN Trial Summary

This trial will test whether a single treatment of botulinum toxin is better than no treatment for lower limb spasticity caused by stroke or TBI. The study will also look at the safety and tolerability of different doses of botulinum toxin.

Eligible Conditions
  • Spasticity due to Stroke or Traumatic Brain Injury

PATTERN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have received injections in your lower limb to relax spastic muscles with botulinum toxin.
Select...
You did not receive injections in your lower limb to relax spastic muscles with a drug called botulinum toxin and the stroke or traumatic brain injury occurred less than 36 months ago.
Select...
You do not have myasthenia gravis, Lambert-Eaton syndrome, or amyotrophic lateral sclerosis.
Select...
You must be between 18 and 85 years of age.
Select...
You have not received baclofen injections in your spine for spasticity treatment.
Select...
Are you at least 110 pounds?
Select...
You have problems with muscle tightness and stiffness in your legs caused by a stroke or head injury.
Select...
You can stand up on your own or with help.
Select...
You can lie down flat and fully straighten your knee.
Select...
You are not currently pregnant or breastfeeding.

PATTERN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4-6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4-6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in derived Modified Ashworth Scale-Bohannon (MAS) ankle score (knee extended) at weeks 4 to 6
Co-Primary: Global Impression of Change Scale (GICS) assessed by physician at Week 4 to 6
Occurrence of treatment emergent adverse events [TEAEs] in the Main Period
Secondary outcome measures
Change from Study Baseline in Goal Attainment Scale [GAS] at Week 6
Global Impression of Change Scale (GICS) assessed by the caregiver at Week 4 to 6
Global Impression of Change Scale (GICS) assessed by the study subject at Week 4 to 6

Side effects data

From 2019 Phase 3 trial • 256 Patients • NCT02270736
12%
Respiratory tract infection viral
9%
Pharyngitis
9%
Respiratory tract infection
9%
Rhinitis
6%
Viral infection
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLEX: NT 201 (Age 2 to 5 Years)
Double-blind MP: Placebo (Age 6 to 17 Years)
Double-blind, MP: NT 201 (Age 6 to 17 Years)
Open-label, MP: NT 201 (Age 2 to 5 Years)
OLEX: NT 201 (Age 6 to 17 Years)

PATTERN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NT 201 (IncobotulinumtoxinA, Xeomin)Experimental Treatment1 Intervention
Main Period (1 treatment cycle): subjects to receive intramuscular injection of NT 201 (400 units) into muscles of the lower limb. Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
Group II: PlaceboPlacebo Group2 Interventions
Main Period (1 treatment cycle): subjects to receive intramuscular placebo injection into muscles of the lower limb. Open Label Extension Period (4-5 treatment cycles): subjects to receive intramuscular injection of NT 201 (up to 800 units) into muscles of the lower limb and upper limb, if indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NT 201
2015
Completed Phase 4
~1380

Find a Location

Who is running the clinical trial?

Merz Pharmaceuticals GmbHLead Sponsor
74 Previous Clinical Trials
12,763 Total Patients Enrolled
1 Trials studying Spasticity
351 Patients Enrolled for Spasticity
Merz Medical ExpertStudy DirectorMerz Pharmaceuticals GmbH
38 Previous Clinical Trials
6,507 Total Patients Enrolled
1 Trials studying Spasticity
351 Patients Enrolled for Spasticity

Media Library

NT 201 (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT03992404 — Phase 3
Spasticity Research Study Groups: NT 201 (IncobotulinumtoxinA, Xeomin), Placebo
Spasticity Clinical Trial 2023: NT 201 Highlights & Side Effects. Trial Name: NCT03992404 — Phase 3
NT 201 (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03992404 — Phase 3
Spasticity Patient Testimony for trial: Trial Name: NCT03992404 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is NT 201 used to treat?

"NT 201 is an effective intervention for patients experiencing urinary incontinence, spinal cord damage, and botox-related issues."

Answered by AI

Are there previous examples of NT 201's usage in research?

"There are currently 68 ongoing clinical trials researching NT 201. Of these, 22 are in Phase 3. Most of the research is centered around Farmington Hills, Michigan; however, there are 761 locations where clinical trials for NT 201 are taking place."

Answered by AI

Is this research being conducted at multiple locations within the city?

"With 9 locations currently running this study, patients have plenty of options for participating. Some of the sites include Merz investigational site #0010441 in Stamford, Rehabilitation Hospital, Kessler Institute for Rehabilitation and Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283 in Columbia."

Answered by AI

Has NT 201 received regulatory approval from the FDA?

"NT 201 has received a score of 3 for safety. This is because NT 201 is in Phase 3 clinical trials, meaning that there is both efficacy and safety data available."

Answered by AI

How many individuals are participating in this research?

"600 individuals that fit the pre-determined inclusion criteria are required for this study. These participants can choose to be seen at locations such as New England institute for clinical research, Merz Investigational Site #0010441 in Stamford, Connecticut or Rehabilitation Hospital, Kessler Institute for Rehabilitation, Merz Investigational Site #0010199 in West Orange, New jersey."

Answered by AI

Are people with the specific ailment still being recruited for this experiment?

"Yes, the trial is still ongoing and seeking participants. According to the information available on clinicaltrials.gov, this study was first posted on September 16th, 2019 and is looking for 600 patients from 9 different locations."

Answered by AI

To whom does this study grant access?

"This trial is open to 600 participants that have suffered a brain injury and range in age from 18 to 85 years old."

Answered by AI

Are the individuals in this trial legally allowed to provide consent?

"According to the study's eligibility requirements, patients must be aged between 18-85. There are a total of 226 studies for people under 18 and 1,832 for seniors above 65 years old."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
New England institute for clinical research; Merz Investigational Site #0010441
Medical College of Wisconsin,Department of PM&R, Merz Investigational Site #0010237
University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Wisconsin
New York
Other
Texas
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

What is the process? How long is the study? Any new medicines used? Is there any compensation?
PatientReceived 2+ prior treatments
How do I enroll in the program?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have CP. I want to walk. I enjoy advancing science. I am responding to a post on Facebook.
PatientReceived no prior treatments
I want help with the stiffness in my legs.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283: < 24 hours
  2. University of Texas Health Science Center McGovern, Medical School Department of PM&R; merz investigational site #0010183: < 48 hours
  3. Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
2019. "Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03992404.
~129 spots leftby Aug 2025
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